(255 days)
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient replacing the unmaged the components. Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
The DePuy Ceramic Femoral Heads are available in a diameter of 28mm, with various offset options. The internal bore which is designed to interlock with the external taper on DePuy femoral stems is available in two variations. The Ceramic Heads are intended to attach to femoral stems, thereby providing the femoral articular surface of a total hip replacement. The DePuy Ceramic Femoral Heads are made from an alumina composite material.
This submission describes the DePuy Femoral Heads, a ceramic femoral ball prosthesis, and its substantial equivalence to previously cleared devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence | The DePuy Ceramic Femoral Heads are identical in design and indications to ceramic femoral heads previously cleared. Testing has shown that minor adjustments do not affect the performance of the device. (This implies that the device meets the performance characteristics of its predicate, which is the implicit acceptance criterion for 510(k) submissions focusing on substantial equivalence.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an AI/ML device. Instead, it refers to "testing" that was performed to demonstrate that minor adjustments to the device did not affect its performance. This suggests bench testing or mechanical testing rather than human performance studies with a specific data set.
- Sample Size: Not specified.
- Data Provenance: Not specified, but likely from internal lab testing given the nature of the device and the claim of "identical in design" to a predicate. It would be retrospective in the sense that the design changes were already made and then tested.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable as the device is a ceramic femoral head (a physical orthopedic implant), not an AI/ML device that requires expert-established ground truth for its performance evaluation in this context. The "truth" here relates to the mechanical and material properties meeting established standards or being equivalent to a predicate.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable as the device is a physical orthopedic implant and not an AI-assisted diagnostic or therapeutic tool for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a physical orthopedic implant, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" implicitly used for this device would be:
- Mechanical and material property specifications: The device's physical properties (e.g., strength, wear resistance, biocompatibility) are expected to meet established industry standards for ceramic femoral heads and/or match those of the legally marketed predicate devices.
- Performance of predicate device: The benchmark for performance is the known and accepted performance of the predicate ceramic femoral heads currently on the market.
8. Sample Size for the Training Set
This is not applicable as the device is a physical orthopedic implant. There is no training set in the context of machine learning. The design and manufacturing processes are refined through engineering principles and iterative testing, not through AI training on a dataset.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set. The "ground truth" for the development of such a device would be based on engineering design principles, material science, biomechanical requirements for hip implants, and compliance with relevant ISO standards for medical devices and materials.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.